Global Paradise System US Post Approval Study

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

June 28, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

July 31, 2031

Conditions
HypertensionCardiovascular DiseasesVascular Diseases
Interventions
DEVICE

Paradise Ultrasound Renal Denervation Treatment

"The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause high blood pressure. The Paradise procedure uses ultrasound energy to calm the nerves near the kidneys to help lower blood pressure.~Treatment is usually done in an outpatient setting and typically takes about an hour to perform. As a part of the treatment, a small flexible tube (catheter) is guided into the blood vessels near the kidneys and 7 seconds of ultrasound energy is applied 2-3 times. Both sides are treated and then the catheter is removed, leaving nothing behind. After the procedure, some people go home the same day or some stay overnight."

Trial Locations (32)

10016

RECRUITING

NYU Langone Health - Bellevue Hosptial, New York

10032

RECRUITING

Columbia University Medical Center/New York Presbyterian Hospital, New York

11794

RECRUITING

Stony Brook Medicine, Stony Brook

14203

RECRUITING

University at Buffalo, Buffalo

17110

RECRUITING

UPMC Harrisburg, Harrisburg

22042

RECRUITING

Inova Fairfax Hospital, Fairfax

27599

RECRUITING

University of North Carolina at Chapel Hill School of Medicine, Chapel Hill

27705

RECRUITING

Durham VA Health System, Durham

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

29303

RECRUITING

Spartanburg Regional Medical Center, Spartanburg

29425

RECRUITING

Medical University of South Carolina, Charleston

32504

RECRUITING

Ascension Sacred Heart, Pensacola

32605

RECRUITING

The Cardiac & Vascular Institute, Gainesville

33136

RECRUITING

University of Miami Health System, Miami

33614

RECRUITING

Tampa Cardiovascular Interventions and Research, Tampa

37205

RECRUITING

Ascension Saint Thomas, Nashville

48202

RECRUITING

Henry Ford Health, Detroit

62702

RECRUITING

Southern Illinois University, Memorial Medical Center, Springfield

64111

RECRUITING

Saint Luke's Mid America Heart Institute, Kansas City

67214

RECRUITING

Ascension via Christi St. Francis, Wichita

70112

RECRUITING

Touro Infirmary, New Orleans

77339

RECRUITING

TCR Institute, Kingwood

78705

RECRUITING

Ascension Seton, Austin

80045

RECRUITING

Rocky Mountain Regional VAMC, Aurora

84124

RECRUITING

St. Mark's Hospital, Salt Lake City

95816

RECRUITING

Sutter Institute for Medical Research, Sacramento

95817

RECRUITING

UC Davis Medical Center, Sacramento

98122

RECRUITING

Swedish Medical Center, Seattle

06610

RECRUITING

Bridgeport Hosptial, Bridgeport

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

The Brigham and Women's Hospital, Boston

08053

RECRUITING

Virtua Health, Marlton

All Listed Sponsors
lead

ReCor Medical, Inc.

INDUSTRY